In an information point published on October 21, 2020, the National Medicines Safety Agency (ANSM) recalls the dangers of isotretinoin during pregnancy. This drug used to treat acne problems, carries a risk of malformations in babies exposed in utero.
175 pregnancies affected each year
As a reminder, isotretinoin is a drug derived from vitamin A used against acne. Originally marketed under the name Roacutane®, this medication is now available in pharmacies in generic form: Procuta®, Curacné®, Contracné®, Acnetrait®.
In an information point dated October 21, the National Medicines Safety Agency recalled the dangers of isotretinoin in pregnancy: “ Despite the measures put in place to improve the proper use of drugs composed of isotretinoin, the number of pregnancies in treated women exposing unborn children to the risk of serious malformations, remains high. Psychiatric disorders also continue to be reported with these drugs. ”
In total, there have been no less than 175 pregnancies exposed to isotretinoin each year since 2010. Indeed, this teratogenic drug presents a high risk of serious malformations, as the ANSM reminds us: ” The use of these drugs during pregnancy is an absolute contraindication due to the very high risk of serious malformations (more than 30%) in exposed fetuses such as abnormalities of the brain, face or heartr ”.
The ANSM recalls the prescription conditions for isotretinoin
In its point of information, the ANSM begins by recalling that isotretinoin must be prescribed as a last intention for the treatment of severe acne, only in the event of failure of conventional treatments. In addition, an isotretinoin treatment is carried out for a period of four to six months and is, most of the time, unique.
The National Medicines Safety Agency reiterated its warning about the use of isotretinoin during pregnancy. Its use must therefore comply with the conditions defined in the Pregnancy Prevention Program which are:
- The establishment of effective contraception at least one month before treatment, during and one month after the end of treatment because of the persistence of isotretinoin in the blood.
- Performing pregnancy tests before taking treatment, every month during treatment and one month after the end of treatment.
- The patient’s awareness of the teratogenic risk of isotretinoin and the signing of the care agreement as well as the hand delivery of the patient information brochure, the liaison letter and the patient card.
Finally, in case of pregnancy during treatment, the body recommends stopping the treatment immediately and seeing a doctor quickly.
